Single handed deployment handle

ABSTRACT

The present invention is directed to an improved delivery system to deliver and deploy a prosthesis in a body lumen, and methods of use thereof. The improved delivery system allows for operation of the delivery system with one hand while maintaining accuracy in delivery and deployment of the prosthesis. An exemplary embodiment of the delivery system includes a first sheath control on a housing so as to be accessible from the exterior of the housing, wherein the first sheath control is operatively engaged with the sheath and controls movement of the sheath axially proximally with respect to the housing, thereby releasing at least a portion of the prosthesis.

RELATED APPLICATION DATA

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/379,146, filed Sep. 1, 2010.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Exemplary embodiments of the present invention relate to systems andmethods for delivering a prosthesis to a desired location in the body.More particularly, the present invention relates to a delivery systemfor deploying a prosthesis within a body lumen and to methods ofdelivering a prosthesis to a desired location in a body. The deliverysystem can be operated with one hand while maintaining accuracy andproviding mechanical advantage in deployment of a prosthesis in a bodylumen.

2. Background

Vascular aneurysms are the result of abnormal dilation of a bloodvessel, usually resulting from disease and/or genetic predispositionthat weakened the arterial wall and allowed it to expand. Whileaneurysms could occur in any blood vessel, most occur in the aorta andperipheral arteries, with the majority of aortic aneurysms occurring inthe abdominal aorta, usually beginning below the renal arteries andoften extending into one or both of the iliac arteries.

Aortic aneurysms were commonly treated in open surgical procedures wherethe diseased vessel segment was bypassed and repaired with an artificialvascular graft. While considered to be an effective surgical technique,particularly considering the alternative of a fatal ruptured abdominalaortic aneurysm, conventional vascular graft surgery suffered from anumber of disadvantages. The surgical procedure was complex and requiredexperienced surgeons and well-equipped surgical facilities. Even withthe best surgeons and equipment, however, patients frequently wereelderly and weakened from cardiovascular and other diseases, reducingthe number of eligible patients.

Even for eligible patients prior to rupture, conventional aneurysmrepair had a relatively high mortality rate, usually from 2% to 10%.Morbidity related to the conventional surgery included myocardialinfarction, renal failure, impotence, paralysis, and other conditions.Additionally, even with successful surgery, recovery took several weeks,and often required a lengthy hospital stay.

In order to overcome some or all of these drawbacks, endovascularprosthesis placement for the treatment of aneurysms has been used.Although promising, many of the proposed methods and apparatusessuffered from undesirable limitations. In particular, accurate deliveryand placement of the endovascular prosthesis within the vasculature wasproblematic.

Stent-grafts (endovascular prostheses) are resilient structures, usuallybiased to expand against a surrounding luminal wall. Suchresiliently-expanding stent-grafts may be tightly compressed within acatheter for delivery, imposing significant radial expansion forcesagainst the surrounding catheter sheath. This may lead to high levels offriction between the stent-graft and the sheath, particularly if theresiliently-expanding structure becomes partially embedded in the sheathmaterial. Thus, a delivery system must be capable of imparting asignificant, yet controlled, force to retract the sheath and deploy thestent-grafts.

U.S. Pat. No. 7,419,501 to Chiu et al., which is incorporated herein byreference in its entirety, discloses a delivery system that attempts toaddress these issues by providing a delivery system having a handle thatallows for accurate placement of a stent-graft in a body lumen. Thedelivery system includes a sheath and a handle. The handle includes: aslide shaft having a threaded outer surface; and a hub assembly coupledto the sheath. The hub assembly includes: an inner slider having athread tooth pivot support; a thread tooth pivotably mounted to thethread tooth pivot support; and a sleeve having a thread tooth pressmember pressing on the thread tooth, where motion of the sleeve relativeto the inner slider pivots the thread tooth on the thread tooth pivotsupport to engage and disengage the hub assembly with the threaded outersurface.

U.S. application Ser. No. 13/106,110, filed May 12, 2011, which isincorporated herein by reference in its entirety, discloses a deliverysystem having an improved handle that allows for operation of thedelivery system with one hand while maintaining accuracy in delivery anddeployment of a prosthesis in a body lumen. The delivery system includesa sheath and a handle. The handle includes: a slide shaft having athreaded outer surface; and a hub assembly coupled to the sheath. Thehub assembly includes: an inner slider having a thread tooth pivotsupport; a thread tooth pivotably mounted to the thread tooth pivotsupport; a distal sleeve having a thread tooth press member pressing onthe thread tooth; and a proximal sleeve. Motion of the distal sleeverelative to the inner slider pivots the thread tooth on the thread toothpivot support to engage and disengage the hub assembly with the threadedouter surface. The distal sleeve is rotatably coupled to the proximalsleeve, and the proximal sleeve is prevented from rotating in order toprovide a stable grip to allow operation of the catheter with one hand.

BRIEF SUMMARY OF THE INVENTION

Some embodiments of the present invention provide improved deliverysystems that allow for operation of the delivery system with one handwhile maintaining accuracy in delivery and deployment of a prosthesis ina body lumen.

Some embodiments of the present invention also provide methods of usingan improved delivery system that allows for operation of the deliverysystem with one hand while maintaining accuracy in delivery anddeployment of a prosthesis in a body lumen.

Additional features of the invention will be set forth in thedescription that follows, and in part will be apparent from thedescription, or may be learned by practice of the invention

Some embodiments of the present invention provide a delivery system fordelivering a prosthesis to a location in a body, the delivery systemincluding a housing having a longitudinal axis and a distal end hole, asheath extending from within the housing through and outwardly beyondthe distal end hole, wherein the sheath contains the prosthesis at adistal end thereof, a first sheath control disposed on the housing so asto be accessible from the exterior of the housing, wherein the firstsheath control is operatively engaged with the sheath, a stop disposedwithin the housing, the stop being engagable and disengagable withrespect to the sheath and configured to, when engaged, confine axialmotion of the sheath with respect to the housing within set parameters,and a stop control accessible from the exterior of the housing andoperatively connected to the stop, wherein actuation of the stop controlcauses the stop to disengage or engage with respect to the sheath,wherein a first actuation of the first sheath control causes the sheathto move axially proximally with respect to the housing, therebyreleasing at least a portion of the prosthesis.

Some embodiments of the present invention also provide a method ofdelivering a prosthesis to a desired location in a body, the methodincluding introducing a sheath of a delivery system into a patient'svasculature, wherein a distal tip of the sheath contains the prosthesis,advancing the distal tip of the sheath to the desired location in thebody, actuating, in a first direction, a sheath control of the deliverysystem to cause the sheath to move axially proximally with respect tothe housing until further motion of the sheath is prevented by a stop,thereby releasing at least a portion of the prosthesis, actuating a stopcontrol to disengage the stop, and continuing to actuate the sheathcontrol in the first direction until the prosthesis is fully released,wherein the sheath control is disposed on a housing of the deliverysystem so as to be accessible from the exterior of the housing, andwherein the sheath control is operatively engaged with the sheath, andwherein the stop control is disposed on the housing of the deliverysystem so as to be accessible from the exterior of the housing, andwherein actuation of the stop control causes the stop to disengage orengage with respect to the sheath.

Both the foregoing general description and the following detaileddescription are exemplary and explanatory and are intended to providefurther explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying figures, which are incorporated herein, form part ofthe specification and illustrate embodiments of prosthetic deliverysystems and methods of delivering a prosthesis to a desired location ina body. Together with the description, the figures further serve toexplain the principles of and to enable a person skilled in the relevantart(s) to make and use the delivery systems and methods describedherein. In the drawings like reference characters indicate identical orfunctionally similar elements.

FIG. 1 is a perspective view of a delivery system according to anexemplary embodiment of the present invention.

FIG. 2 is a top view of a delivery system according to an exemplaryembodiment of the present invention.

FIG. 3 is a side view of a delivery system according to an exemplaryembodiment of the present invention.

FIG. 4 is a perspective view of a delivery system according to anexemplary embodiment of the present invention.

FIG. 5 is a perspective view of a delivery system according to anexemplary embodiment of the present invention.

FIG. 6 is a perspective view of a delivery system according to anexemplary embodiment of the present invention.

FIG. 7 is a perspective view of a delivery system according to anexemplary embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description of prosthetic delivery systems andmethods of delivering a prosthesis to a desired location in a bodyrefers to the accompanying figures that illustrate exemplaryembodiments. Other embodiments are possible and may fall within thescope of the present invention. Modifications can be made to theexemplary embodiments described herein without departing from the spiritand scope of the present invention. Therefore, the following detaileddescription is not meant to be limiting. Further, it would be apparentto one of skill in the art that the systems and methods described belowcan be implemented in many different embodiments of hardware. Any actualhardware described is not meant to be limiting. The operation andbehavior of the systems and methods presented are described with theunderstanding that various modifications and variations of the exemplaryembodiments may be within the scope of the present invention.

FIG. 1 is a perspective view of a delivery system 100 according to anexemplary embodiment of the present invention. FIG. 2 is a top view ofan exemplary embodiment of delivery system 100. FIG. 3 is a side view ofan exemplary embodiment of delivery system 100. Delivery system 100includes a housing 120, a first sheath control 150, a stop control 152,and a sheath 170. Housing 120 can include proximal portion 110(sometimes referred to as a “handle” or “grip”) and distal portion 130.Distal portion 130 can include a distal end hole 138.

A distal tip of sheath 170 can releasably contain a prosthesis (notshown). A user can operate delivery system 100 by inserting sheath 170containing the prosthesis in its distal tip into a body lumen of apatient. The user can then position the distal tip of sheath 170 withinthe patient's body lumen in a desired location. The user can thenoperate delivery system 100 to withdraw sheath 170, thereby releasingthe prosthesis at the desired location in the patient's body lumen.

Sheath 170 extends from within housing 120 through and outwardly beyonddistal end hole 138. Sheath 170 can removably contain a prosthesis (notshown) within its distal end. The prosthesis can be held in position bya prosthesis retainer (not shown) mounted to a delivery shaft (notshown) connected to housing 120.

U.S. application Ser. No. 13/106,110, filed May 12, 2011, which ishereby incorporated by reference in its entirety, discloses systems andmethods of controlling motion of a sheath with respect to a housing. Asone skilled in the art would appreciate, similar systems and methods canbe used in conjunction with the present invention. The presentinvention, however, is not limited to such use.

First sheath control 150 is mounted to housing 120 so as to beaccessible and operable from the exterior of housing 120. First sheathcontrol 150 can be selectively engaged and disengaged with sheath 170.When engaged, first sheath control 150 can be operated to move sheath170 axially with respect to housing 120. When first sheath control 150is operated to move sheath 170 proximally with respect to housing 120,sheath 170 can gradually release the prosthesis from its distal end,because the prosthesis will be held axially stationary with respect tohousing 120 by the prosthesis retainer and/or delivery shaft. If theprosthesis is only partially released, first sheath control 150 can beoperated to move sheath 170 distally with respect to housing 120,thereby recapturing the prosthesis within the distal end of sheath 170.

First sheath control 150 can operatively engage with sheath 170 in avariety of ways that would be apparent to one of skill in the art. Forexample, first sheath control 150 can include interior threads or otherengagement members that align with exterior threads or other engagementmembers on sheath 170 such that rotation of first sheath control 150causes axial translation of sheath 170 with respect to housing 120, orsheath 170 can be fixed to a slide shaft that engages first sheathcontrol 150 to cause axial translation of sheath 170 in response tooperation of first sheath control 150. Preferably first sheath control150 can engage with sheath 170 so as to provide mechanical advantage andprecise control to a user of sheath control 150 in order to facilitaterelease or recapture of the prosthesis.

In an exemplary embodiment, first sheath control 150 includes awheel-shaped control member aligned coaxially with housing 120 androtatable thereabout. First sheath control 150 can be positioned betweenproximal portion 110 and distal portion 130 so as to be easilyaccessible to a user of delivery system 100. First sheath control 150can cover a portion of housing 120 where proximal portion 110 and distalportion 130 meet, or first sheath control 150 can itself form a part ofhousing 120 by itself joining proximal portion 110 and distal portion130. A user will typically grasp proximal portion 110 in one hand suchthat the forefinger and thumb of the user are positioned proximate tofirst sheath control 150. Because of the location of first sheathcontrol 150 relative to proximal portion 110 (i.e., grip), as well asthe mechanical advantage and precision control provided by first sheathcontrol 150, the user can operate first sheath control 150 to release orrecapture the prosthesis with the forefinger and thumb of the user'shand while grasping proximal portion 110 with the remaining fingers andthe palm, without the need to employ the user's other hand. First sheathcontrol 150 can be configured such that it does not travel in an axialdirection with respect to housing 120.

Delivery system 100 can also include a sheath stop that, when engaged,limits the axial motion of sheath 170 with respect to housing 120. Thesheath stop can be configured to allow axial motion of sheath 170 torelease only a portion of the prosthesis. Such a feature can provide anindication of how much of the prosthesis has been released, or indicatethe point after which recapture of the prosthesis cannot effectivelytake place. Stop control 152 (sometimes referred to as “stop release” or“⅔ stop release”) can be actuated to disengage the sheath stop, therebyallowing axial motion of sheath 170 beyond the limits imposed when thesheath stop is engaged (e.g., allowing axial motion of sheath 170 to itsfull proximal position). Typically a user would operate stop control 152to release the sheath stop once the user is certain of proper placementof the prosthesis. Thereafter, the user can operate first sheath control150 to further and fully release the prosthesis. As shown in FIG. 1, inan exemplary embodiment stop control 152 is a ring located at the distalend of first sheath control 150. To actuate stop control 152 and therebydisengage the sheath stop, a user applies pressure to stop control 152in a distal direction.

First sheath control 150 can include gripping enhancements 154 on itssurface to assist a user in turning first sheath control 150. FIGS. 1-3depicts ridges extending longitudinally and disposed around the exteriorof the wheel of first sheath control 150. Other gripping enhancementscan also be used. For example, raised bumps, circular ridges, surfacetexture, or indents can be disposed on a surface of first sheath control150. Such gripping enhancements decrease the likelihood that a user'sfingers will slip while operating first sheath control 150, and increasethe ease with which the user can operate first sheath control 150.

Additionally, first sheath control 150 can include a control indicator156. Control indicator 156 also can enhance a user's grip on firstsheath control 150, however it is shaped differently from grippingenhancements 154. The different shape of control indicator 156 providestactile feedback to a user operating first sheath control 150, and canthereby indicate to the user the degree to which the first sheathcontrol 150 has rotated.

In some situations, it may be desirable to have more direct control overthe movement of sheath 170 than may be provided by first sheath control150. In an exemplary embodiment, housing 120 includes a second sheathcontrol 112 (also referred to as a “proximal indicator”) accessiblethrough a proximal slot 114 extending longitudinally along and through aportion of proximal portion 110. Second sheath control 112 can be fixedto sheath 170 and axially slidable with respect to housing 120. Secondsheath control 112 moves within slot 114 during operation of firstsheath control 150 as a consequence of first sheath control 150 movingsheath 170. Because second sheath control 112 is accessible through slot114, it can be viewed by a user, thereby providing to the user anindication of the extent of movement of sheath 170. As an alternative tomoving sheath 170 using first sheath control 150, a user can chooseinstead to move sheath 170 using second sheath control 112. As the usergrips proximal portion 110, the user can position his or her thumb (orother portion of his or her hand) on second sheath control 112 and slidesecond sheath control 112 proximally or distally within proximal slot114, thereby causing a corresponding movement of sheath 170. Such use ofsecond sheath control 112 to control sheath 170 may be desirable to auser for a variety of reasons. For example, the user can withdraw sheath170 more quickly with second sheath control 112 than operation of firstsheath control 150 would allow.

Depending on the configuration of first sheath control 150, a user'scontrol of the movement of sheath 170 by way of second sheath control112 may be inhibited by the engagement of first sheath control 150 withsheath 170. To alleviate this difficulty, an exemplary embodiment of thepresent invention includes a sheath engagement control 118, operable todisengage or engage first sheath control 150 with sheath 170. As shownin FIG. 1, in an exemplary embodiment sheath engagement control 118coexists with second sheath control 112. This configuration allows auser to apply pressure to sheath engagement control 118 (e.g., bypressing down on sheath engagement control 118 with his or her thumb) todisengage first sheath control 150 from sheath 170, at which point theuser can slide second sheath control 112 so as to control movement ofsheath 170. The user can release the pressure applied to sheathengagement control 118 in order to re-engage first sheath control 150with sheath 170. In some exemplary embodiments, sheath engagementcontrol 118 need not be held down to keep first sheath control 150disengaged with sheath 170, but need only be pressed once to disengage,and once again to re-engage.

Housing 120 can optionally include a proximal flush port 116 in proximalportion 110, and/or a distal flush port 136 in distal portion 130.Proximal flush port 116 and distal flush port 136 can be used to flushcavities within sheath 170 with fluid in order to prevent introducingair into a patient during delivery of the prosthesis.

Distal portion 130 can include a distal slot 134 extendinglongitudinally along and through distal portion 130. A distal indicator132 may be viewable to a user through distal slot 134. Distal indicator132 is connected to sheath 170 and slidable within distal portion 130along with motion of sheath 170. As such, distal indicator 132 canindicate to a user the extent to which sheath 170 has moved in responseto the user's operation of either first sheath control 150 or secondsheath control 112.

FIG. 4 is a perspective view of a delivery system 400 according to anexemplary embodiment of the present invention. Description of elementsof the exemplary embodiment depicted in FIG. 4 that are the same oroperate similarly as those described above with reference to FIGS. 1-3may be omitted or abbreviated.

In an exemplary embodiment of the present invention, a delivery system400 includes a first sheath control 450 that includes a wheel-shapedcontrol member rotatably mounted to a housing 420 (housing 420 includinga proximal portion 410 and a distal portion 430). First sheath control450 can be positioned on housing 420 so as to be easily accessible to auser of delivery system 400. A user will typically grasp proximalportion 410 (i.e., grip) in one hand such that the forefinger and thumbof the user are positioned proximate to first sheath control 450.Because of the location of first sheath control 450 relative to proximalportion 410, as well as the mechanical advantage and precision controlprovided by first sheath control 450, the user can operate first sheathcontrol 450 to release or recapture the prosthesis with the forefingerand/or thumb of the user's hand that is grasping proximal portion 410,without the need to employ the user's other hand. In order to facilitatesuch operation, first sheath control 450 can be provided with gripenhancers 454, which, in the embodiment of FIG. 4, are grooves extendingaround the circumference of first sheath control 450 in an axialdirection with respect to first sheath control 450.

Delivery system 400 can also include a sheath stop that, when engaged,limits the axial motion of sheath 170 with respect to housing 420. Astop control 452 can be actuated to disengage the sheath stop, therebyallowing axial motion of sheath 170 beyond the limits imposed when thesheath stop is engaged (e.g., allowing axial motion of sheath 170 to itsfull proximal position). Typically a user would operate stop control 452to release the sheath stop once the user is certain of proper placementof the prosthesis. Thereafter, the user can operate first sheath control450 to further and fully release the prosthesis. As shown in FIG. 4, inan exemplary embodiment stop control 452 is a button located in thecenter of first sheath control 450. To actuate stop control 452 andthereby disengage the sheath stop, a user applies pressure to stopcontrol 452.

Delivery system 400 can also include a sheath engagement control 418that is separate from second sheath control 112 and is slidably disposedon the exterior surface of housing 420. Sheath engagement control 418 islocated proximate to first sheath control 450 so as to allow forsingle-handed access by a user. Sheath engagement control 418 isslidable in an axial direction with respect to housing 420 between aproximal position and a distal position. Sliding sheath engagementcontrol 418 from one position to the other disengages or engages firstsheath control 450 with sheath 170. For example, sliding sheathengagement control from the proximal position to the distal position cancause sheath engagement control 418 to disengage first sheath control450 with sheath 170, at which point a user can slide second sheathcontrol 112 so as to control movement of sheath 170. The user can slidesheath engagement control 418 from the distal position to the proximalposition in order to re-engage first sheath control 450 with sheath 170.In some exemplary embodiments, sheath engagement control 418 isspring-loaded such that it resists sliding from the proximal position tothe distal position. In such an exemplary embodiment, a user who hasslid sheath engagement control 418 to a distal position in order todisengage first sheath control 450 with sheath 170 need only releasesheath engagement control 418 in order to allow sheath engagementcontrol 418 to return to the proximal position and re-engage firstsheath control 450 with sheath 170.

FIG. 5 is a perspective view of a delivery system 500 according to anexemplary embodiment of the present invention. Description of elementsof the exemplary embodiment depicted in FIG. 5 that are the same oroperate similarly as those described above may be omitted orabbreviated.

In the embodiment shown in FIG. 5, a delivery system 500 includes afirst sheath control 550 that includes a wheel-shaped control memberrotatably mounted to a housing 520 (housing 520 including a proximalportion 510 and a distal portion 530) such that the axis of the wheel isoffset from the longitudinal axis of housing 520. First sheath control550 can be partially recessed within housing 520 such that a portion ofthe exterior surface of first sheath control 550 extends through thesurface of housing 520 so as to be accessible from the exterior ofhousing 520. A user can operate first sheath control 520 by rotating theportion of first sheath control 520 that extends outside housing 520. Auser will typically grasp proximal portion 510 in one hand such that thethumb of the user is positioned proximate to first sheath control 550.Because of the location of first sheath control 550 relative to proximalportion 510 (i.e., grip), as well as the mechanical advantage andprecision control provided by first sheath control 550, the user canoperate first sheath control 550 to release or recapture the prosthesiswith the thumb of the user's hand that is grasping proximal portion 510,without the need to employ the user's other hand. In order to facilitatesuch operation, first sheath control 550 can be provided with gripenhancers 554, which, in the exemplary embodiment of FIG. 5, are groovesextending around the circumference of first sheath control 550 in anaxial direction with respect to first sheath control 550.

Delivery system 500 can also include a combination stop control andsheath engagement control 556. Combination stop control and sheathengagement control 556 can be a three-position switch, with a middleposition, a left position, and a right position. Combination stopcontrol and sheath engagement control 556 can be a cylindrical elementextending through a portion of housing 520 so as to protrude fromopposing sides of housing 520, where a user can operate combination stopcontrol and sheath engagement control 556 by pressing on either end.Combination stop control and sheath engagement control 556 is notlimited to a cylindrical element. For example, combination stop controland sheath engagement control 556 can be rectangular, triangular, orhexagonal.

Combination stop control and sheath engagement control 556 is shown inFIG. 5 in the middle position. When in the middle position, pressing ona right side of combination stop control and sheath engagement control556 will cause combination stop control and sheath engagement control556 to slide from the middle position to the left position, and pressingon the left side of combination stop control and sheath engagementcontrol 556 will cause combination stop control and sheath engagementcontrol 556 to slide from the middle position to the right position.When in the left position, pressing on a left side of combination stopcontrol and sheath engagement control 556 will cause combination stopcontrol and sheath engagement control 556 to slide from the leftposition to either the middle position or the right position, dependingon how far combination stop control and sheath engagement control 556 ispressed. When in the right position, pressing on a right side ofcombination stop control and sheath engagement control 556 will causecombination stop control and sheath engagement control 556 to slide fromthe right position to either the middle position or the left position,depending on how far combination stop control and sheath engagementcontrol 556 is pressed.

Of the three potential positions for combination stop control and sheathengagement control 556, one will be a first position in which firstsheath control 550 is engaged with sheath 170 and a sheath stop isengaged. Another will be a second position in which first sheath control550 is disengaged with sheath 170 and the sheath stop is engaged.Another will be a third position in which first sheath control 550 isengaged with sheath 170 and the sheath stop is disengaged. As will beappreciated by one of skill in the art, more or fewer than threepositions are possible for combination stop control and sheathengagement control 156, and combinations of first sheath control 550 andsheath stop states other than those described are possible.

In some exemplary embodiments, combination stop control and sheathengagement control 556 can be spring-loaded so as to naturally tend toremain in a neutral position. The neutral position can correspond to themiddle position. In such an exemplary embodiment, the portions ofcombination stop control and sheath engagement control 556 that extendon either side of housing 520 can each correspond independently to oneof a stop control and a sheath engagement control. For example, a usercan depress and release the left side of combination stop control andsheath engagement control 556 in order to engage or disengage the sheathstop, regardless of the state of engagement of the first sheath control550 with the sheath 170. Correspondingly, the user can depress andrelease the right side of combination stop control and sheath engagementcontrol 556 in order to engage or disengage first sheath control 550with the sheath 170, regardless of the state of the sheath stop.Alternatively, rather than a single member protruding from opposingsides of housing 520, combination stop control and sheath engagementcontrol 556 can include two separate protrusions, acting as buttonsextending from either side of housing 520, each independently performingthe functions of either a stop control or a sheath engagement control.

It should be noted that although the terms “left” and “right” are usedabove in relation to the position of combination stop control and sheathengagement control 556, these terms are used for convenience ofdescription only, and are not meant to be limiting. As one of skill inthe art would appreciate, the described positions can be oriented otherthan left and right, for example “top” and “bottom”, “proximal” and“distal”, and the like.

FIG. 6 is a perspective view of a delivery system 600 according to anexemplary embodiment of the present invention. Description of elementsof the exemplary embodiment depicted in FIG. 6 that are the same oroperate similarly as those described above may be omitted orabbreviated.

In an exemplary embodiment of the present invention, a delivery system600 includes a first sheath control 650 that includes a lever-basedcontrol member mounted to a housing 620 (housing 620 including aproximal portion 610 and a distal portion 630) such that the leverextends in a substantially axial direction with respect to housing 620,albeit angled thereto, depending on its state. First sheath control 650is shown in FIG. 6 as being mounted near a midpoint of housing 620, withits lever extending in a distal direction with respect to housing 620.The lever of first sheath control 650 can be moved toward or away fromhousing 620. Movement of the lever in one direction will cause thesheath to move proximally with respect to the housing, thereby at leastpartially releasing the prosthesis. Movement of the lever in the otherdirection will cause the sheath to move distally with respect to thehousing, thereby recapturing at least a portion of the prosthesis, ifthe prosthesis has not already been fully released.

Because of the location of first sheath control 650 on housing 620, aswell as the mechanical advantage and precision control provided by firstsheath control 650, the user can operate first sheath control 650 usinghis or her thumb and index finger while holding housing 620 with thepalm and remaining fingers. to release or recapture the prosthesis withthe fingers of the user's hand that is grasping 620, without the need toemploy the user's other hand. In order to facilitate such operation,first sheath control 650 can be provided with grip enhancers 654, which,in the embodiment of FIG. 6, are grooves extending across the lever offirst sheath control 650.

It should be noted that although the lever of first sheath control 650is shown in FIG. 6 as being mounted near a midpoint of housing 620, withits lever extending in a distal direction with respect to housing 620,this configuration is exemplary, and is not meant to be limiting. As oneof skill in the art would appreciate, sheath control 650 can bepositioned in a variety of configurations with respect to housing 620.For example, first sheath control 650 could be mounted near a midpointof housing 620 with its lever extending in a proximal direction withrespect to housing 620, or it could be mounted near an endpoint (eitherproximal or distal) of housing 620 with its lever extending toward theopposing endpoint of housing 620.

Delivery system 600 can also include a sheath stop that, when engaged,limits the axial motion of sheath 170 with respect to housing 620. Astop control 652 can be actuated to disengage the sheath stop, therebyallowing axial motion of sheath 170 beyond the limits imposed when thesheath stop is engaged (e.g., allowing axial motion of sheath 170 to itsfull proximal position). Typically a user would operate stop control 652to release the sheath stop once the user is certain of proper placementof the prosthesis. Thereafter, the user can operate first sheath control650 to advance and fully release the prosthesis. As shown in FIG. 6, inan exemplary embodiment stop control 652 is a slidable control memberdisposed on the exterior surface of housing 620. Stop control 652 can belocated on housing 620 under or proximate to the lever of first sheathcontrol 650. This positioning facilitates easy single-handed access by auser. As described above, a user can grasp delivery system 600 with onehand such that his or her fingers wrap around housing 620 and arepositioned on or proximate to the lever of first sheath control 650. Insuch a position, the user's fingers would be positioned proximate tostop control 652. Stop control 652 is slidable in an axial directionwith respect to housing 620 between a proximal position and a distalposition. Sliding stop control 652 from one position to the otherdisengages or engages the sheath stop. For example, sliding sheath stopcontrol 652 from the distal position to the proximal position can causesheath stop control 652 to disengage, at which point a user can continueto operate first sheath control 650 to move sheath 170 beyond the limitsotherwise imposed by the sheath stop.

Delivery system 600 can also include a sheath engagement control 618that is separate from second sheath control 112 and is slidably disposedon the exterior surface of housing 620. Sheath engagement control 618can be located on a side of housing 620 opposite to that of first sheathcontrol 650. This positioning facilitates single-handed access by auser. Sliding sheath engagement control 618 from one position to theother disengages or engages first sheath control 650 from sheath 170.For example, sliding sheath engagement control 618 from the proximalposition to the distal position can cause sheath engagement control 618to disengage first sheath control 650 with sheath 170, at which point auser can slide second sheath control 112 to control movement of sheath170. The user can slide sheath engagement control 618 from the distalposition to the proximal position in order to re-engage first sheathcontrol 650 with sheath 170. In some exemplary embodiments, sheathengagement control 618 is spring-loaded such that it resists slidingfrom the proximal position to the distal position. In such an exemplaryembodiment, a user who has slid sheath engagement control 618 to adistal position in order to disengage first sheath control 450 withsheath 170 need only release sheath engagement control 618 in order toallow sheath engagement control 618 to return to the proximal positionand re-engage first sheath control 650 with sheath 170.

FIG. 7 is a perspective view of a delivery system 700 according to anexemplary embodiment of the present invention. Description of elementsof the exemplary embodiment depicted in FIG. 7 that are the same oroperate similarly as those described above may be omitted orabbreviated.

In an exemplary embodiment of the present invention, a delivery system700 can include a first sheath control 750 aligned coaxially withrespect to a housing 720. First sheath control 750 includes grippingenhancements 754. First sheath control 720 will operate similarly tofirst sheath control 150, described above with reference to FIGS. 1-3.Delivery system 700 can also include a combination stop control andsheath engagement control 756 positioned near a distal end of housing720. Such combination stop control and sheath engagement control 756will operate similarly to combination stop control and sheath engagementcontrol 556, described above with reference to FIG. 5.

Delivery system 700 can also include a second sheath control 712extending longitudinally from a proximal end of housing 720. Secondsheath control 712 can be fixed to sheath 170 and axially slidable withrespect to housing 720. Second sheath control 712 can move proximally ordistally with respect to housing 720 during operation of first sheathcontrol 750 as a consequence of first sheath control 750 moving sheath170. Because second sheath control 712 extends from the proximal end ofhousing 720, it can be viewed by a user, thereby providing to the useran indication of the extent of movement of sheath 170. As an alternativeto moving sheath 170 by way of first sheath control 750, a user canchoose instead to move sheath 170 by way of second sheath control 712.As the user grips housing 720, the user can position a rear portion ofhis or her hand on second sheath control 712, and can slide secondsheath control 712 proximally or distally with respect to housing 720,thereby causing a corresponding movement of sheath 170 and at leastpartial release or recapture of the prosthesis.

While various exemplary embodiments of the present invention have beendescribed above, they have been presented by way of example only, andnot limitation. The elements of the exemplary embodiments presentedabove are not necessarily mutually exclusive, but can be interchanged tomeet various needs as would be appreciated by one of skill in the art.Although the exemplary embodiments presented above allow a user tooperate the delivery devices with one hand, it would be appreciated byone of skill in the art that the exemplary embodiments can also beoperated with multiple hands, or with a single hand and another bodypart or implement.

It therefore will be apparent to one skilled in the art that variouschanges in form and detail can be made to the exemplary embodimentsdisclosed herein without departing from the spirit and scope of thepresent invention. The phraseology or terminology herein is used fordescription and not for limitation. Thus, it is intended that thepresent invention cover modifications and variations of this inventionprovided they come within the scope of the appended claims and theirequivalents.

What is claimed is:
 1. A delivery system for delivering a prosthesis to a location in a body, the delivery system comprising: a housing having a longitudinal axis; a sheath extending from within the housing; a first sheath control coupled to the housing and accessible from the exterior of the housing, wherein the first sheath control is configured to operatively engage with the sheath, wherein a first actuation of the first sheath control causes the sheath to move axially in a proximal direction with respect to the first sheath control to release at least a portion of the prosthesis if the first sheath control is engaged with the sheath; a sheath engagement control coupled to the housing and accessible from the exterior of the housing, wherein the sheath engagement control selectively engages and disengages the first sheath control from the sheath; and a second sheath control coupled to and movable axially with respect to the housing, wherein the second sheath control is fixed to the sheath such that the sheath moves axially with the second sheath control to release or retract at least a portion of the prosthesis with the sheath engagement control actuated such that the first sheath control is disengaged from the sheath.
 2. The delivery system of claim 1, wherein the first sheath control does not move axially with respect to the housing.
 3. The delivery system of claim 1, wherein a second actuation of the first sheath control causes the sheath to move axially in a distal direction with respect to the housing.
 4. The delivery system of claim 3, wherein the first actuation comprises moving the first sheath control in a first direction, and wherein the second actuation comprises moving the first sheath control in a second direction, the second direction being different from the first direction.
 5. The delivery system of claim 1, wherein the first sheath control comprises a wheel, the wheel being rotatably mounted to the housing.
 6. The delivery system of claim 5, wherein the wheel is disposed such that the axis of the wheel coincides with the longitudinal axis of the housing.
 7. The delivery system of claim 5, wherein the wheel is disposed such that the axis of the wheel intersects the longitudinal axis substantially perpendicularly.
 8. The delivery system of claim 5, wherein the wheel is disposed such that the axis of the wheel extends transversely with respect to the housing, and wherein the axis of the wheel is offset from the longitudinal axis.
 9. The delivery system of claim 1, wherein the first sheath control comprises a lever.
 10. The delivery system of claim 1, wherein the housing comprises a proximal slot extending longitudinally through a side surface of the housing, and wherein the second sheath control is accessible and axially slidable within the proximal slot.
 11. The delivery system of claim 1, further comprising a stop control coupled to the housing and accessible from the exterior of the housing, wherein actuation of the stop control disengages or engages a sheath stop that, when engaged, allows axial motion of the sheath but limits the extent of the axial motion of the sheath.
 12. The delivery system of claim 11, wherein the stop control and the sheath engagement control coexist together as a single control member.
 13. A method of delivering a prosthesis to a desired location in a body, the method comprising: introducing a sheath of a delivery system into a patient's vasculature, wherein the sheath contains the prosthesis; advancing the distal tip of the sheath to the desired location in the body; actuating, in a first direction, a first sheath control of the delivery system to cause the sheath to move proximally with respect to the first sheath control, thereby releasing at least a portion of the prosthesis, wherein the first sheath control is accessible from the exterior of a housing of the delivery system, and wherein the first sheath control is operatively engaged with the sheath; actuating a sheath engagement control to cause the first sheath control to disengage from the sheath, wherein the sheath engagement control selectively engages and disengages the first sheath control from the sheath, and with the sheath engagement control actuated such that the sheath control is disengaged from the sheath, actuating a second sheath control of the delivery system to cause the sheath to move axially with the second sheath control to release or retract at least a portion of the prosthesis.
 14. The method of claim 13, further comprising actuating, in a second direction, the first sheath control of the delivery system to cause the prosthesis, once partially released, to retract within the sheath.
 15. The method of claim 13, wherein the first sheath control does not move axially with respect to the housing.
 16. The method of claim 13, wherein actuating the second sheath control comprises: axially sliding the second sheath control within a proximal slot extending longitudinally through a side surface of the housing, wherein the second sheath control is fixed to the sheath such that axially sliding the second sheath control causes the sheath to move axially with respect to the housing.
 17. The method of claim 13, further comprising: actuating the first sheath control in the first direction with a stop engaged until further motion of the sheath is prevented by the stop; actuating a stop control of the delivery system to disengage the stop; continuing to actuate the first sheath control in the first direction until the prosthesis is fully released, wherein the stop control is accessible from the exterior of the housing of the delivery system, and wherein actuation of the stop control causes the stop to disengage or engage with respect to the sheath. 